Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001269820
Ethics application status
Approved
Date submitted
4/12/2012
Date registered
4/12/2012
Date last updated
4/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Cerebral Palsy Child: a prospective cohort study of motor development and brain structure in young children with cerebral palsy.
Scientific title
Australian Cerebral Palsy Child- a prospective cohort study of motor development and brain structure in young children, with cerebral palsy born in Queensland in 2006, 2007, 2008 and 2009.
Secondary ID [1] 281579 0
Nil
Universal Trial Number (UTN)
Trial acronym
CPchild
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 287861 0
Condition category
Condition code
Musculoskeletal 288220 288220 0 0
Other muscular and skeletal disorders
Neurological 288266 288266 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Longitudinal measurement of Gross Motor Function (GMFM 66), Gross motor function classification, motor type, distribution(bilateral, unilateral), brain structure (location, extent, presumed timing of lesion), classification of comorbidities(epilepsy,vision,hearing,health status), musculoskeletal development, participation and relationship between motor prognosis and resource use at 18 months, 2 years, 30 months, 3 years, 4 years and 5 years corrected age.
Intervention code [1] 286102 0
Not applicable
Comparator / control treatment
Comparisons will be made between children in the different Gross Motor Function Classification System (GMFCS) categories.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288416 0
Longitudinal measurement of Gross Motor Function (GMFM 66)
Timepoint [1] 288416 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age
Primary outcome [2] 288417 0
Classification of brain injury by Magnetic Resonance Imaging (MRI).
The brain will be classified by the anatomical features of the lesion, the presumed aetiology and the presumed timing of the insult that caused the lesion.
Timepoint [2] 288417 0
MRI from 2 years
Secondary outcome [1] 300101 0
Gross motor function classification status(GMFCS I-V),
Timepoint [1] 300101 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age
Secondary outcome [2] 300137 0
Motor type Motor type (spastic, dystonic, hypotonic and distibution (unilateral, bialteral and number of limbs involved) will be classified according to
the Surveillance of Cerbral Palsy in Europe guidelines and the North American Task Force on Childhood Motor Disorders
Timepoint [2] 300137 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years of age
Secondary outcome [3] 300138 0
Clinical history and examination by medical personnel at study entry
Classification of co-morbidities: epilepsy, vision, hearing and health status
Timepoint [3] 300138 0
at time of entry to the study, may be at either 18 months, 2 years , or at 30 months, 3 years, 4 years or 5 years.
Secondary outcome [4] 300139 0
Hip displacement:
Hip displacement will be assessed by 6 monthly pelvic radiographs with radiological measures migration percentage (MP), acetabular index (AI), Hilgenreiners Epiphyseal angle
Timepoint [4] 300139 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years.
Secondary outcome [5] 300140 0
Resource use and direct costs of treatment:
In order to determine the relationship between motor prognosis and resource use, medical resource use and the direct costs of treatment will be monitored and compared to outcomes with adjustment for confounders such as disease severity using cost and consequence analysis.
Timepoint [5] 300140 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years
Secondary outcome [6] 300141 0
Upper limb function.
The Manual Assessment Clsssification System will be used to classify hand function based on the child's typical performance when handling objects in daily activities.
Timepoint [6] 300141 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years
Secondary outcome [7] 300176 0
Communication difficulties by parent self-report on the Communication and Symbolic Behaviour Scales-Development Profile (CSBS-DP)
Timepoint [7] 300176 0
18 months, 2 years, 30 months, 3 years, 4 years and 5 years

Eligibility
Key inclusion criteria
All children diagnosed with cerebral palsy, born in Victoria between 1 January 2004 and 31 December 2005; and in Queensland between 1 January 2006 and 31 December 2009.
We define cerebral palsy a a group of permanent disorders of movement and posture that attributed to non-progressive disturbances that occurred in the developing foetal or infant brain. The characteristic signs are spasticity, movement disorders, muscle weakness, ataxia and rigidity.
Minimum age
18 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a progressive or neurodegenerative lesion will be excluded from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286397 0
Government body
Name [1] 286397 0
National Health and Medical Research Council
Country [1] 286397 0
Australia
Funding source category [2] 286398 0
Charities/Societies/Foundations
Name [2] 286398 0
Telstra Community Development Fund
Country [2] 286398 0
Australia
Funding source category [3] 286399 0
Other Collaborative groups
Name [3] 286399 0
Murdoch Childrens Research Institute
Country [3] 286399 0
Australia
Primary sponsor type
Individual
Name
Professor Roslyn Boyd
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 7 Block 6
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 285198 0
Individual
Name [1] 285198 0
A/Prof Michael Fahey
Address [1] 285198 0
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria 3168
Country [1] 285198 0
Australia
Secondary sponsor category [2] 285199 0
Individual
Name [2] 285199 0
A/Prof Barry Rawicki
Address [2] 285199 0
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria 3168
Country [2] 285199 0
Australia
Other collaborator category [1] 277206 0
Hospital
Name [1] 277206 0
Royal Children's Hospital
Address [1] 277206 0
Royal Children's Hospital
Herston Rd
Herston
Queensland 4029
Country [1] 277206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288469 0
The Royal Children's Hospital, Melbourne
Ethics committee address [1] 288469 0
Ethics committee country [1] 288469 0
Australia
Date submitted for ethics approval [1] 288469 0
Approval date [1] 288469 0
22/12/2006
Ethics approval number [1] 288469 0
25010F
Ethics committee name [2] 288480 0
Southern Health Ethics Committee C
Ethics committee address [2] 288480 0
Ethics committee country [2] 288480 0
Australia
Date submitted for ethics approval [2] 288480 0
Approval date [2] 288480 0
07/09/2005
Ethics approval number [2] 288480 0
05077C
Ethics committee name [3] 288481 0
Queensland Children's Health Services(RCH) Human Research Ethics Committee
Ethics committee address [3] 288481 0
Ethics committee country [3] 288481 0
Australia
Date submitted for ethics approval [3] 288481 0
Approval date [3] 288481 0
31/10/2007
Ethics approval number [3] 288481 0
HREC/07QRCH/107
Ethics committee name [4] 288496 0
Mater Health Services
Ethics committee address [4] 288496 0
Ethics committee country [4] 288496 0
Australia
Date submitted for ethics approval [4] 288496 0
Approval date [4] 288496 0
14/07/2008
Ethics approval number [4] 288496 0
1186C

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34977 0
Address 34977 0
Country 34977 0
Phone 34977 0
Fax 34977 0
Email 34977 0
Contact person for public queries
Name 18224 0
Professor Roslyn Boyd
Address 18224 0
Queensland Cerebral Palasy and Rehabilitation Research Centre
Level 7 Block 6
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 18224 0
Australia
Phone 18224 0
+61 7 3365 5315
Fax 18224 0
Email 18224 0
[email protected]
Contact person for scientific queries
Name 9152 0
Professor Roslyn Boyd
Address 9152 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 7 Block 6
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 9152 0
Australia
Phone 9152 0
+61 7 3365 5315
Fax 9152 0
Email 9152 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.